Clinical Trials Logo

Clinical Trial Summary

The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen). The main question is • the change of weight (%) before and after complete treatment of breast cancer therapy. Participants will be randomized into 2 group - intervention group - receive medical supplement daily during chemotherapy treatment. - control group - Nutritional advise during chemotherapy treatment.


Clinical Trial Description

1. The rational is to prove the hypothesis is that, the effect of medical supplement with nutritional advise can prevent the reduction of body weight, malnutrition and treatment complication, which eventually to improve of the quality of life. 2. Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital. Secondary endpoints are nutritional status (PG-SGA), quality of life. 3. Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 40 patients. 4. Randomization into 2 groups. Intervention arm : receive medical supplement daily (1 drink = 6 scoops in 250 ml water, 2 drinks/day) with nutritional advise. Control arm : nutritional advise only. Duration of treatment is 12 weeks 5. Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system. 6. Data assessment on week 0,6,12 during chemotherapy treatment. 7. Data analyzed by descriptive statistics to characterize patients at entry. We did the efficacy analyses with intention to treat population 8. We did analyses with R version 3.3.0. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06311357
Study type Interventional
Source Rajavithi Hospital
Contact Meitinarth Juntong
Phone +66654415447
Email juntong.mei@gmail.com
Status Recruiting
Phase N/A
Start date July 12, 2023
Completion date April 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT02816112 - Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia Phase 4
Completed NCT02816164 - A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia Phase 4
Completed NCT03946683 - Cyberknife for Early Stage Breast Cancer N/A
Recruiting NCT04458532 - Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer N/A
Completed NCT01162200 - Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer Phase 1
Completed NCT01965522 - Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer Phase 2
Completed NCT00309569 - Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients Phase 3
Terminated NCT01545648 - Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer Phase 2
Completed NCT02428114 - A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study) N/A
Active, not recruiting NCT02685332 - Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA Phase 1
Completed NCT02159157 - A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer N/A
Completed NCT01871116 - POWER-remote Weight Loss Program in Early Stage Breast Cancer N/A
Terminated NCT01166581 - Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates N/A
Terminated NCT02364960 - Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
Active, not recruiting NCT03561454 - A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients
Completed NCT02485678 - A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer N/A
Active, not recruiting NCT02297672 - Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant N/A
Completed NCT02335671 - Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy N/A
Completed NCT03102307 - Registry Trial to Evaluate the Clinical Utilization of Targeted Axillary Dissection (TAD)
Recruiting NCT04607473 - ABUS for Early-stage Breast Cancer N/A